FDA Product Code OUK: Surgical Mask With Antimicrobial/antiviral Agent
A Single Use, Disposable Surgical Mask For Occupational Use To Cover The Nose And Mouth Of The Wearer To Protect From The Transfer Of Microorganisms,body Fluids And Particulates And Has An Added Antimicrobial And/or Antiviral Agent Which Kills Specific Pathogens Under Specified Contact Conditions.
Leading manufacturers include Prestige Ameritech.
FDA 510(k) Cleared Surgical Mask With Antimicrobial/antiviral Agent Devices (Product Code OUK)
About Product Code OUK - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code OUK since 2011, with 4 receiving FDA clearance (average review time: 265 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OUK have taken an average of 449 days to reach a decision - up from 204 days historically. Manufacturers should account for longer review timelines in current project planning.
OUK devices are reviewed by the General Hospital panel. Browse all General Hospital devices →